1.A. Field of the Invention
In the 20th century, medication principally addressed illness which was ‘incident’, i.e. relating to an injury, an infection, or an infestation; and the best health results came from public health efforts (safe water, personal hygiene, vaccinations). Across the globe the average lifespan surged upwards, in some places at more than a year's gain for each year of progress. These now are seen as “easy victories” over the most broadly-shared killer ills; for in the 21st century people remain mortal and health care's share of our national GNP has more than doubled.
This century starts with an estimate that in the United States alone 133 million people suffer from at least one chronic illness, and the reality that chronic illnesses lead to approximately seven out of every ten deaths in the United States each year. Medications often prescribed to alleviate and treat these chronic illnesses fail principally because current levels of adherence to medication regimens are at or below 50%. Patients, even those with access to preventative or palliative medications, are not properly treating their chronic diseases, this century's major killers.
Taking medication sounds simple in theory. As with most of life, reality presents a host of complications. For all that there are standard and approved regimens, reality includes transient, temporary, interruptions; context-specific deviations; emergency changes; and always purely ‘human’, but reality-based, differences between the theoretical (standard) ideal and the pragmatic real-time and real-world experience(s). For and as part of each specific, prescribed regimen, each human being experiences and causes divergences between his or her planned, or prescribed, dosage and the reality of what doses (and when) he or she actually takes.
A patient may have difficulty remembering to take his medicine at the recommended time(s). Or a patient may have difficulty remembering that she has already taken a dose. Some patients have difficulty remembering the recommended dose of medicine, especially if that dose requires more than one unit (pill) of the same medicine. The reality is even more convoluted for any multiple drug regimen, and one mistake may pose grave consequences to the patient. These problems both especially true and may compound for patients (like elderly, disabled and cognitively impaired individuals, or patients with psychiatric disorders) with inadequate skills or knowledge to follow a medicine regimen, and those facing a language barrier. An increasing segment of the population joins those most vulnerable as their regimens individually comprise multiple medicines, each with a different schedule and instructions.
As eyesight fades with age reading labels of medicine containers can present a problem. Even young, alert patients can be overwhelmed by life, work, family and other responsibilities and forget to take their medicines. This is especially apparent with temporary treatments (e.g. antibiotics), when the medicine is taken for a period of time too short to generate a routine.
Then add to all of the above rapid changes in the selection of formulary (and thus features of the actual pills), packaging errors, and intentional or inadvertent switching of medications amongst containers, that lead to divergences between what is thought to be in a container and what is actually dispersed at the time of use. The end result is too often that the amount of medicine actually taken is too low to affect the treatment, or so high as to cause an overdose, or that the wrong medication entirely is taken.
Patient compliance with medication dosing schedules is a serious problem. Approximately 60% of prescribed medication is not taken as directed. Non-compliance leads to worsening illness, hospitalization, irreversible loss of function, and death, resulting in tremendous human and financial costs. When medicines are dispensed, especially outside hospitals, errors in selection of the correct pill and the appropriate dose add further morbidity and mortality.
For example, elderly patients and patients taking multiple medications at different dosing schedules may have difficulty remembering to take their medications at the scheduled times. Approximately 90% of elderly patients make medication errors, 35% of which are serious. Approximately 40% of all hospital admissions among elderly patients are due to medication problems.
The gold standard remains supervised administration of each dose of each medication and of the integrated medical regimen by a highly-educated professional (doctor, nurse, pharmacist, or other medical specialist); but for most situations this is costly overkill. Even though medical professionals on average do worse than the medial performance attainable with automatic support systems, whether such be as simple as a checklist (Atul Gawande) or as complex as an advanced medical robot (Intuitive Surgical's da Vinci machines).
The current state of the art has many methods and systems seeking to effect proper medication by individuals, because such actions are important—sometimes literally vital—in preventing sickness, complications, and even death. Many machines and methods have been proscribed, prescribed, and even patented in this field.
Giving instructions and then letting patients fend for themselves has been shown not to work particularly well. For improper taking of medicines only is not the greatest medical danger. Rather, it is any unsensed or untracked divergence between medical presumption and real-time performance, which gives rise to improper feedback, which then leads to the physician concluding that it is the medicine and not the actual regimen that is failing—which then causes the physician to change the wrong factor (dose, timing, or even choice of drug) in a mistaken effort that fixes the wrong problem. These divergences can be frustrating to both patient and physician, detrimental to the experienced care for the chronic illness, and increase costs for no gain; yet be simply and readily correctible or handleable within an existing treatment regimen when truthfully managed.
1.B. Description of the Related Art
A number of systems and devices already exist that provide instructions, alarms, or assistance to a user regarding when to take at least one medication, and/or to record its having been taken. These include ordinary pen, paper, Post-It® notes, and refrigerator-front reminder magnets. All incorporate one fundamental defect: they presume a perfect linear progression from alert to event, and thus diverge from reality whenever the user's actual behavior does not match the preconceived and pre-set process. Prior inventors defined their goal as trying to meet “The need for a device that will automatically dispense the proper pill(s) in the proper amount(s) at the proper time(s) each day and alert the user of the devise to take the dispensed pills . . . . ” (U.S. Pat. No. 8,068,931, “Systems and Methods for Monitoring Pill Taking”, Tran, A. A. A. et al., issued Nov. 29, 2011, Col. 1, lines 18-21).
Thus the prior art is rife with simplifying, perfectionist, and unrealistic presumptions. Most share that of U.S. Pat. No. 5,915,558, “Portable Pill Box With Alarm”, Girvetz. N., issued Jun. 29, 1999, which is substantially as its title describes. This invention presumptively links opening the access door to the storage area with correctly taking the content(s) therein: “If the pills are accessed (door 40 is opened and/or a vial is removed), then the acknowledge signal will indicate that the contents of the pill box have been accessed in response to the alarm signal.” (Col. 5, lines 51-54) The contents, number of units (pills) taken, and even presence of the ‘vial’, are all presumed correct; and “access” is presumed to be flawlessly linked to ingestion.
U.S. Pat. No. 6,604,650, “Bottle-Cap Medication Reminder And Overdose Safeguard”, Sagar, R. B., issued Aug. 12, 2003, also presumptively links opening the cap with taking the content(s) therein: “The cap would use the time it was last removed (as detected by the sensor) as the datum for the Time since last dose.” (Col. 4, lines 64-65)
U.S. Pat. No. 6,779,663, “System and Method for Loading Pills Into A Pillbox”, Pocsi, J. P., issued Aug. 24, 2004, is aimed at the pharmacist and/or her assistant, or the persons providing the medication, rather than those taking it—or more specifically, at the steps of preparing a medicine dispenser for future use, rather than at the point-and-time of use for specific and particular dose(s). This invention's core “latticework pattern of rows and columns” (Col. 3 lines 18-19) and “loader form” (Col. 12, line 8) are not any part of the present invention.
U.S. Pat. No. 7,081,807, “Automatic Pill Reminder Bottles”, Lai, J., issued Jul. 25, 2006, concedes that it is merely “a reminder device to remind user to take pill regularly” [sic] (Col. 1, lines 46-47). As with Sagar/U.S. Pat. No. 6,604,650, it links the opening and closing of the bottle to the presumptive taking of the correct dose.
U.S. Pat. No. 7,269,476, “Smart Medicine Container”, Ratnakar, Nitesh, issued Sep. 11, 2007, presumptively links dispensation of the medication with its being correctly taken; and further depends on the correct ‘bulk’ medication being loaded into the container in the first place (Col. 15, line 21) and not broken or disturbed before or upon dispensation. As with the preceding patents, “The time of opening of the outlet door (22) is recorded as ‘consumption time’ by the sensor (23) . . . . ” (Col. 10, lines 27-38) This patent is advanced over the earlier ones, for it contains a sensor in the dispensation channel to count each pill that is dispensed (Col. 14, line 58), and a second sensor in the outlet transition (Col. 15, lines 1-4); thus it does not presume that the right number have been removed when the timer is activated and the door opened.
U.S. Pat. No. 7,395,214, “Apparatus, Device and Method for Prescribing, Administering and Monitoring a Treatment Regimen For a Patient”, Shillingburg, C., issued Jul. 1, 2008, describes such a device and approach eminently well; its system and device provides instruction to a patient regarding the medications to be taken. Furthermore, the system supposedly may determine whether a specific prescription is appropriate given the patient's conditions and other medications he or she may already be taking. That system also supposedly may monitor compliance of the patient with such a regimen through its dispensing of medicine in accordance with a predetermined treatment protocol. While that system offers improvements over ‘prescribe and pray’ approach, it presumes perfection in use and operation, for that system provides no mechanism for actually confirming that a patient is in fact ingesting or otherwise properly administering required medication, which it presumptively links to the dispenser being opened. As itself states:                “the Device enables the Doctor . . . to verify that the patient actually opened the Device (and presumptively took a pill) . . . ” (Col. 13, lines 20-22; emphasis added)        
That invention may be sufficient for one who is in full possession of their mental faculties; but not help any individual who may have difficulty following directions, or one who is actively avoiding medication; either may still not be taking required medication after it is dispensed. Furthermore, it requires preloading of various medications into a dispenser and has no function to check whether the medication which is actually dispensed is that which is intended; so if there is any error in the loading, this invention has no way to detect (and thus correct) it at the time a dose is dispensed. While this patent does suggest that “each of the chambers 370 may be uniquely configured (based on the size and configuration of a given medication) to filter pills through the device and into the patient accessible chamber 378” (Col. 19, lines 63-66), or an alternative having “customized sleeves that are inserted into the chambers” (Col. 19, line 1; FIG. 3H, 3I), even if an administering manager regularly visits to ensure appropriate medications are loaded, it is surely possible that an inexperienced or momentarily inattentive loader may place incorrect medications into the device (or chamber), or may somehow provide incorrect dosages into the device. It has no test for mis-loaded and thus mis-dispensed medications. It uses “as a medication transferring device, a slide tray 380” (Col. 19, lines 4-5).
Finally, not only does this invention's description openly state its presumption that each time a pill is taken out it is (a) at the time, correctly being removed, and (b) taken; it lacks any check on whether the count of pills taken out was correct, or means to either replace the pill or to account for it not being taken (and thus any ability to reverse the presumption of perfect compliance based on reality experienced by the user).
U.S. Pat. No. 7,359,765, “Electronic Pill Dispenser”, Varvarelis, N. M. et al., issued Apr. 15, 2008, also depends on the correct medication being loaded in the first place into its “ . . . receptacle for storing and dispensing any size of pill P . . . ” (Col. 4, line 34). It (as with the cited prior art) fails to check whether what is being dispensed is a pill P, or a pea, or a stone, or a pill not-P.
U.S. Pat. No. 7,877,268, “Intelligent Pill Box”, Kulkarni, A. U., issued Jan. 25, 2011, links removal of an individual pill container with the taking of the correct dosage of that medication (though with flawed English from a pro se applicant):                “If the pill box is lifted after this signal then the green flashing LED will glow continuously green with no beep sound. (This will indicate that the person is taking the pill).” [Sic] (Col. 6, lines 59-62)        “But if the person keeps back the vial within 20 sec. then Smart-Pill-Box assumes that the pill has not been consumed.” [Sic] (Col. 6, line 66-Col. 7, line 1)        “If the person keeps the vial back after 20 sec. Smart-Pill-Box records that the pill has been consumed and sends the data to server through telephone line.” [Sic] (Col. 7, lines 3-5)        
Although this patent's specification asserts that the device weighs the contents of the pill box (Col. 6, lines 13-18), examination of the claims, and perusal of the image file wrapper, disclose this aspect was not asserted during the prosecution of the patent, and further disclose that the examiner's allowance was predicated solely on the timing intervals relating to the removal and replacement of the pillbox within the device as part of its “Dispensing Scheme” (Col. 6, line 55-Col. 7, line 13). The specification fails to provide any operative instruction sufficient to meet a 35 U.S.C. §112 ‘enablement’ requirement as to how the device effects this functionality.
U.S. Pat. No. 7,896,192, “Patient-Controlled Timed Medication Dispenser”, Conley, N. S. et al., issued Mar. 1, 2011, addressed the need for medication which may not be delivered at a pre-fixed schedule but instead may have a first dose delivered at a time of the patient's selection, yet which prohibits access to a further dose until a minimum time interval has elapsed. The device also controls access through an authentication operation, and stores a record of its operation. The invention presumes that presentation of the medication in an ‘open’ container is equated with the patient taking the medication, even though it limits the presentation time preferentially to less than half a minute. (Col. 11, lines 27-30) The passage of time alone—not whether any medication is removed—is used to establish that a dose was taken. (Col. 11, lines 30-35) This lack of feedback means that half of the potential dose-carrying sites are empty. (Col. 11, lines 49-51; Col. 12, lines 10-12, 65-67) Should the patient not meet the window of opportunity and take the dose when presented, the invention presumes that all of the minimum necessary interval must first pass—“if . . . the dose is not removed from the retention area”, except that “the patient can request a dose from the attendant”. (Col. 14, lines 25-27; lines 27-28) The literal blindness of this patent to alternative approaches can be seen in its provision for a sensor (Col. 15, line 25) that is only used to determine whether a medication area is properly aligned (Col. 15, lines 31-34), and not whether any medication is in the medication area. Later, however, while it describes a ‘dose presence detector 757’ (Col. 19, line 39), this is its only mention—no use or connection exists elsewhere in the Specification. This detector only functions to detect removal—not the presence, or introduction—of a dose (Col. 19, lines 50-52) and is not mentioned in any of the claims.
U.S. Pat. No. 7,907,477, “Bottle Cap Medication Timer”, Puzia, Scott; issued Mar. 15, 2011, comprises solely a “disposable electronic timer” (Abstract, line 1) which has timer-setting and control buttons, only.
U.S. Pat. No. 7,993,055, “Method and Apparatus for Alerting A Person At Medicine Dosing Times”, Nurse, C. L. et al., issued Aug. 9, 2011, chiefly differs from U.S. Pat. No. 7,907,477 by not being on the cap, secondarily by excluding any visual display, thirdly by allowing for ‘creep time’, and shares the presumptions that (1) opening the dispenser (switch) is equivalent to the dosage being properly taken (“ . . . activating a switch when an annunciator is activated causes the dosing schedule to advance to the next dosing interval”; Col. 3, lines 42-44; FIG. 5B); and, (2) only the proper medication is in the container (“A method . . . comprises the steps of dispensing medicine into a container . . . . ”; Col. 3, lines 60-61).
U.S. Pat. No. 8,060,249, “Medication Dispenser With Integrated Monitoring System”, Bear, D. M. et al., issued Nov. 15, 2011, requires all of “a plurality of storage compartments” (Col. 1, lines 49-50), “an image capturing device” that sees into each storage compartment (Col. 1, lines 52-54, FIG. 2) and a separate and remote “central monitoring system” to which the device transmits its images (Col. 1, line 56, FIG. 4; Col. 15, lines 26-29; Col. 16, lines 18-20). This invention depends on ensuring compliance through live (albeit remote) observation by human monitors (Col. 5, lines 6-8; Col. 7, lines 19-25; Col. 9, lines 14-17; Col. 13, lines 19-22).
U.S. Pat. No. 8,068,931, “Systems and Methods for Monitoring Pill Taking”, Tran, A. A. A. et al., issued Nov. 29, 2011, also presumptively links the opening of a compartment with the medication(s) within being taken. (Col. 6, lines 39-46; FIGS. 5, 6) The leaps of presumption go further, as the inventors assert that if taken “around normal lunch time when the medication should have been taken on an empty stomach, the system provides a warning and reports the event” (Col. 2, lines 54-56); and initially assume that “multiple compartment openings during one medication dispensing event” leads to a mistaken taking, instead of checking whether the user merely inadvertently opened the wrong compartment without removing anything (Col. 3, lines 17-19). Even for the further embodiment when the weight is directly measured, “the system infers that the pills have been removed and (presumably) taken by the patient” (Col. 7, lines 9-10).
U.S. Pat. No. 8,069,056, “Methods And Apparatus For Increasing And/Or For Monitoring A Party's Compliance With A Schedule For Taking Medicines”, Walker, J. S. et al., issued Nov. 29, 2011, requires a plurality of medicine containers which each contain different medications and wirelessly communicate (Col. 2, lines 56-61; Claim 1, Col. 36, lines 26-28). It also envisions an off-site, third-party “controller 106 may comprise, for example, a computers at an insurance company or medical facility, or . . . an authentication server . . . . ” (Col. 9, lines 55-57). This invention presumes that proximity between the two containers equals compliance (Col. 11, lines 44-46; Col. 16, lines 29-34 and lines 63-67; and particularly, Col. 17, lines 61-63: “ . . . that identify compliance/proximity information regarding the taking of the medicine . . . ”; Col. 21, lines 27-29); though it does include as alternative embodiments allow additionally the use of any of a pressure, weight, or RFID sensors as “any attribute that indicates the patient 104 has complied . . . ” (Col. 24, lines 18-41; Claims 7 & 8, Col. 37, lines 5-10).
U.S. Pat. No. 8,284,068, “Activity Monitor To Alleviate Controlled Substance Abuse”, Johnson, S., issued Oct. 9, 2012, focuses on detecting, collecting, and storing information about when a container “has been moved, opened or otherwise tampered with” (Col. 2, lines 5-6). This invention also presumes that moving or opening a container means that the contents within have been taken (Col. 10, lines 47-50). This invention does consider at least the possibility of feedback, but presumptively associates this as “in response to feedback from other sources . . . ” (Col. 11, lines 16-17).
U.S. Pat. No. 8,269,613, “Smart Cap for a Medicine Container To Dispense A Medication While Self-Verifying Medicine Identity”, Lazar, Steven S., issued Sep. 18, 2012, begins with identifying, discussing, and revealing a few of the limitations of the art prior to its filing. This patent comes closer than some of the others, but presumptively links dispensing the medication with its being taken, without considering the potential that the medication (all or part of the dose) may need to be returned when the patient cannot or should not take it; for the invention in this patent is “to prevent the improper dispensing of the medication” (Col. 4, lines 53-54).
U.S. Pat. No. 8,319,613, “Smart Cap With Communication Function”, Lazar, Steven, issued Nov. 27, 2012, (and a continuation-in-part of U.S. Pat. No. 8,269,613), also shares the presumptive linkage between the dispensing of a medication (correctly) and its being taken (Col. 2, lines 46-48; Claim 1, Col. 9 lines 54-59).
U.S. Pat. No. 8,538,775 (application Ser. No. 11/839,723, issued Sep. 17, 2013), Skomra, S. A., “Mobile Wireless Medication Management System” provides a medication management system employing mobile devices and an imaging technology so that a user is able to show a pill to be taken to the system, and the system can then identify the medication. Patient histories are available to an administrator, including various vital signs as measured by the system. Images may also be taken of the patient, provider, medication container or the like. While the system professes to ensure adherence to a protocol, the system only provides such help if requested by a user. There is in fact no particular manner in which to ensure actual adherence or the relationship of adherence to the efficacy of the drug over time. When customizing a medication regimen or monitoring a personal medication regimen, this is particularly relevant.
U.S. Pat. No. 8,727,180, “Smart Cap System”, Zonana, M. et al., issued May 20, 2014, focuses on the dispensing aspect to enable accurate dispensing of a specific medication dose through a mechanically complex cap mechanism (FIG. 1-11, 13-23). This patent at least contemplated the possibility that an error may follow the dispensation of the dose:                “Thus, if the patient accidentally loses the medication as by dropping it down the drain, etc., and the patient urgently needs to access the medication, the patient may have not choice but to break the seal between the bottle 110 and the device 100 as by pulling the pull tab 1502 of the emergency tab 1500. However, when the patient returns to consultation with the physician and/or seeks refill, it will be immediately evident that the emergency tab 1500 has been removed and this will spur questions and require explanation.” (Col. 12, line 62-Col. 13, line 3)        
In short, that invention's solution to the problem of any post-dispensing error breaks the mechanism and allows no corrective feedback save through an external agent.
U.S. Pat. No. 8,727,208, “Method For Identifying Pills Via An Optical Device”, Poisner, D., issued May 20, 2014, focuses solely on the problem of correctly identifying via an optical device (camera), what medication (composition and dosage) is in an unknown pill, chiefly for the use of emergency and law enforcement personnel and entities (Col. 1, lines 20-34; Col. 7, lines 27-30), instead of chemical analysis; and is not intended to be used by consumers or users of any pill(s).
U.S. Pat. No. 8,754,769, “Systems and Methods for Determining Container Contents, Locations, and Surroundings”, Adhere Tech Inc., et al., issued Jun. 17, 2014, focuses on the specific aspects of using capacitance sensors for sensing the contents of a medication container (Col. 1, lines 21-23). Here, again, the presumption is that removal is the only operative action: “whereby a patient who does not take medicine as expected is reminded (e.g., with different and/or multiple reminders/alerts) until he or she removes the appropriate amount of medication from medication container 102.” (Col. 8, lines 50-54.) This patent does allow the alternative sensing of when a cap has been closed or opened (Col. 9, lines 24-27), then explicitly states its presumptive coupling, “ . . . thus signaling that the patient might have just removed medication from the container” (Col. 9, lines 30-31). Then this patent allows that a measurement might test the first presumption (opening=removal) (Col. 9, lines 33-35), but does not consider whether the second presumptive linking of removal of the medication with the taking of a dose, other than as ‘timing’ or data communication issues. (Col. 9, lines 41-58.) Its only concept of “feedback” is for a “backend system 104” through purely symbolic communication, “(e.g., via text message, email, and/or telephone calls to patients)” (Col. 14, line 6-9).
U.S. Pat. No. 8,781,856, “Method And Apparatus For Verification Of Medication Administration Adherence”, Hanina, A. et al., issued Jul. 15, 2014, requires, as the present application does not, both video capture equipment (Col. 2, lines 64-66) and a third-party remote comparative monitoring of activity of a medication's user to ensure proper compliance with a prescription regimen “to confirm that the medication is being actually and properly taken” (Col. 2, lines 66-67).
U.S. Pat. Appl. 2006/0102649, “Good Cup”, Garukyan, G.; published May 18, 2006, filed Oct. 5, 2004; Application Ser. No. 10/957,902, is merely a device to make removal of a pill from a vial easier.
U.S. Pat. Appl. 2010/0142330, “Attachable Device for Pill Container”, Reygaert, P.; published Jun. 10, 2010, filed Oct. 30, 2007; Application Ser. No. 12/514,026, is a variation on timer-based dispensing which presumptively links access to the contents with dispensing and taking of the medication (¶0012, lines 7-8 thereof; ¶0027).
U.S. Pat. Appl. 2010/0270257, “Medicine Bottle Cap With Electronic Embedded Curved Display”, Wachman, J. S., et al.; published Oct. 28, 2012, filed Apr. 29, 2010; Application Ser. No. 12/770,436, shares the approach of the prior art, that what is needed is support to effect perfect compliance [¶¶0036-0045]. This system also specifically requires a multi-color LED [¶0064, Claim 1] Most importantly, It shares with the prior art the presumption that accessing the medication (opening the specific dispensing point) is equivalent to the medication's being taken:                “The system assumes that if the medicine container has been opened and then closed, that the medication was actually taken and that the dosage was correct. Preferably, the number of pills has to be accounted for upon setup. The known number is decremented by the dosage amount when the cap is opened.” [¶0055]        
U.S. Pat. Appl. 2014/0240094, “Systems And Method For Determining Container Contents, Locations, and Surroundings”, AdhereTech Inc., et al.; published Aug. 28, 2014; filed May 8, 2014; Application Ser. No. 14/273,289, a continuation of U.S. Pat. No. 8,754,769, also focuses on “increasing patient adherence to medication regimes” [¶¶0004; 0029]. This application implements the concept mentioned (without enabling detail) in U.S. Pat. No. 7,877,268 and in the further embodiment of U.S. Pat. No. 8,068,931 [¶0005] for detecting a quantity removed . . . but does not use any deviation from dosage to trigger alternative pathways (emergency under- or overdose concerns, or changed interactions with other medications); its focus is on providing “one or more reminders and/or alerts to the patient to take medication” [¶0037, 10 lines up from bottom of paragraph; ¶0040, 6 lines in]. This application does recognize a single flaw of the prior art in presuming that operating a switch equates to taking a dose, by imposing a timing constraint of a required delay to “prevent container 102 from measuring, recording, and/or reporting back a measurement when a patient accidentally activates the switch (e.g. presses the switch with the patient's finger) before the patient has removed any medication” [¶0048, 2″d column on page, 7 lines down]. Yet its focus relentlessly remains on providing alerts, rather than tracking and managing divergences between prescription regimen and real behavior. (Among other assumptions, this invention presumes the medication has both been correctly loaded and has not deteriorated in storage.)
None of these devices, methods, systems, or prior art inventions fully address the underlying, fundamental problem which separates perfection (or prescription) from performance (reality). The fundamental problem which they do not consider nor address, is neither new, nor can it be solved by the most ingenious, thorough, imaginative, or intrusive alerts, buzzers, timers, reminders, or nagging. It is an old and well-known problem which defeats those more intelligent even more readily than it does those who are less capable. For individuals whose native with most enables them to overcome momentary lapses or to effectively pre-plan against failure, are those least armored in humility and least-likely to insist on the detail-by-detail, action-by-action, step-by-step checking that alone can spot and as necessary correct, or after its eventuation, account, for any unplanned, inadvertent, mishap. This fundamental problem is aptly and readily summarized in the phrase: “There's many a slip twixt the cup and the lip.”
What if a patient finds that the pill dispensed is not what it should be (it is broken, contaminated, or just the wrong dose or medication)? What if a patient (user) takes out a pill too many? Or experiences a momentary interrupt and wants and/or needs to first put the pill back (for safekeeping), so she must be reminded again shortly to take that dose? Suppose the patient is feeling too poorly to take a dose and elects to skip doing so? Or decides she can tolerate only a partial dose? What if a patient has dropped the dispensed pill into the toilet or sink and cannot retrieve it, and so to take his dose, needs a second pill, now?
The prior art—especially as it presumptively links correct dispensation with the dose going into the patient—lacks feedback and error-handling tracking, resolution, and recording to account for divergences “between the cup and the lip”; it cannot adapt to the certainty of human imperfection, nor (for the most part) handle what must happen when the presumption embedded in the prescription fails to match reality.
Admittedly no device or system can be perfect; for while humans can devise myriads of ways to ensure that a dose is actually taken, a resisting patient can respond with a like count of ways to subvert such efforts. Pills can be palmed, tucked under the tongue or into the cheek, or even swallowed and then vomited back up. These measures can defeat even the ‘gold standard’—as experienced medical personnel in psychiatric wards and perhaps a majority of cat owners can attest. The present invention presumes at minimum some level of acceptance (even if grudging or confused) as to the necessity and desirability of adhering to a prescription regimen, rather than active and intentional efforts to subvert and defeat it.
All of the above inventions, because they presume perfection can be engineered into a device used by imperfect people, lack feedback that measures when the theoretical regimen and reality fail to match, means to identify the incident(s) of divergence, error-recording means to track divergences, fallback means to recover from a presumption's failure, or any set of the above; and for each point of presumptive perfection lack in-process, situational, corrective capabilities to handle a divergence at the level closest in time and reality.
Additionally, existing systems that do not track errors by definition fail to maintain an accurate audit trail for post-administration review by medical personnel, and thus cannot confirm proper medication administration whenever an error is experienced. Existing systems are further generally impractical in that they fail to address many aspects of feedback (and non-adherence) which may be critical to proper evaluation of the prescription regimen as it has been experienced by the user, rather than as it was intended and prescribed originally by a medical service provider.
The need for the present invention becomes clearer when the perspective of ‘need’ shifts from that of the provider of the medication to not the provider of the dispensing device, but the user thereof, i.e. the patient.
To solve the problem of errors and divergences at the precise moment of delivery, slips must be looked for and corrected or else recorded exactly and as they occur—thereby providing immediate, specific, and bi-directional feedback as to the operation of the medical regimen in reality. The problem the present invention addresses, the question it asks is: What might be different between the plan (prescription) and reality (this medication this dose this time this user)—and how can the user match the ‘should be’ of the first to the ‘is’ of the second? In short, how differently would the prior art and the present invention handle the situation where a patient drops her dose onto the floor (or worse, into the toilet)?